Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients

Pain Clinical Trial

Official title:

UMCC 2013.051: Prospective Pilot Study Evaluating the Use of Cyclobenzaprine for Treatment of Sleep Disturbance, Fatigue, and Musculoskeletal Symptoms in Aromatase Inhibitor-treated Breast Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01921296
• Other study ID #: UMCC 2013.051
• Status: Terminated
• Phase: Phase 2
• First received: August 8, 2013
• Last updated: May 26, 2015
• Start date: August 2013
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Many women with breast cancer who are treated with aromatase inhibitor medications develop difficulty sleeping and fatigue during treatment. Some examples of aromatase inhibitor medications include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara). Frequently, sleeping pills do not work very well to improve sleep. Cyclobenzaprine (Flexeril) is a medication that was originally developed to treat muscle spasms. It may also improve sleep in patients with chronic pain disorders, such as fibromyalgia. In this study we are testing to see if cyclobenzaprine at bedtime will help improve sleep in women treated with aromatase inhibitors.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female gender, age = 18, postmenopausal.

• Histologically proven stage 0-III invasive carcinoma of the breast

• Initiating or have been receiving a standard dose of aromatase inhibitor therapy (letrozole 2.5mg once daily or exemestane 25mg once daily or anastrozole 1mg once daily) for up to a total of 48 months of AI therapy.

• Trouble sleeping during the past week. (After signing the informed consent document, subjects must also have a global PSQI score of =5)

• ECOG performance status 0-2 (see Appendix A).

Exclusion Criteria:

• Known hypersensitivity to cyclobenzaprine or any of the inactive ingredients

• Diagnosis of sleep apnea that is currently interfering with sleep or requiring CPAP, restless leg syndrome that is currently interfering with sleep or requiring medication, or Epworth sleepiness scale >10.

• Subjects with a history of hypothyroidism must have been on a stable dose of thyroid replacement medicine for at least 3 months prior to enrollment

• Treatment with steroids within 1 month

• Treatment with monoamine oxidase inhibitors (MAO-I) within 14 days of enrollment.

• Concurrent treatment with bupropion, MAO inhibitors, phenothiazines (including thioridazine), selegiline, tramadol, or medications known to prolong the QT interval (www.azcert.org/medical-pros/drug-lists/drug-lists.cfm)

• Currently primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder

• Known moderate or severe hepatic impairment

• History of congestive heart failure or cardiac arrhythmia (other than atrial fibrillation); myocardial infarction within the past 6 months

• Uncontrolled narrow-angle glaucoma

• Pregnant or breast feeding

• Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dyssomnias
• Pain
• Parasomnias
• Sleep Disorders
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Cyclobenzaprine
5 milligrams orally 2 hours before bedtime

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Lynn Henry	Damon Runyon Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of Subjects Who Continue to Take Aromatase Inhibitor Therapy	We will assess the number of patients who continue to take the original aromatase inhibitor medication at the 24 week timepoint, as assessed using patient self-report and medical records	24 weeks	No
Other	Safety and Tolerability of Cyclobenzaprine Therapy	Persistence with cyclobenzaprine therapy for 24 weeks will be assessed using a medication diary. Safety will be assessed using CTCAE criteria	24 weeks	Yes
Primary	Number of Patients That Experience an Improvement in Sleep Quality as Assessed Using the Pittsburgh Sleep Quality Index (PSQI) With 8 Weeks of Cyclobenzaprine Therapy.	Will measure sleep quality using the Pittsburgh Sleep Quality Index at baseline and after 8 weeks of therapy with cyclobenzaprine.	8 weeks	No
Secondary	Change in Fatigue Between Baseline and Week 8 With Cyclobenzaprine Therapy	Will measure fatigue using the PROMIS fatigue questionnaire at baseline and after 8 weeks of therapy with cyclobenzaprine.	8 weeks	No
Secondary	Change in Pain Between Baseline and Week 8 With Cyclobenzaprine Therapy	Will measure pain using the Brief Pain Inventory at baseline and after 8 weeks of therapy with cyclobenzaprine.	8 weeks	No